ISO 13485

Certification Body for Management Systems

Germany

This scope pertains to the accreditation certificate D-ZM-19630-04-00 according to DIN EN ISO/IEC 17021-1:2015, valid from 23.06.2025. It is issued to DNV MEDCERT GmbH in Hamburg, enabling them to conduct conformity assessment activities listed in the document. The certification meets the minimum requirements of ISO/IEC 17021-1 and additional legal and normative requirements, including those in relevant sectoral programs. It also complies with IAF MD 9:2023 for certification bodies operating in the field of quality management systems for medical devices per ISO 13485:2016. The certification covers various non-active medical devices, technical areas, active non-implantable medical devices, active implantable medical devices, in-vitro diagnostics, sterilization methods, and medical products utilizing specific substances/technologies. The scope includes services such as maintenance, transportation, and distribution, with competence verified for certifying organizations involved in the medical product lifecycle, health facilities, and custom manufacturers. This scope also clarifies abbreviations used and limitations on certain services within the certification scope.